Drug Topics - March 2009 - (Page 52) Product Updates WHAT’S NEW RX & OTC New Products 1 2 3 RX CARE New drugs Forest Laboratories and Cypress Bioscience announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the FDA for the management of fibromyalgia. Studies showed that doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful improvements in pain, patient global assessment, and physical function. Patients should be cautioned about risk of bleeding when milnacipran is used with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation. For more information, visit www.cypressbio.com. Allergan announced the FDA has approved Latisse (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. It is approved to enhance eyelash prominence as measured by increased length, thickness, and dark color. For more information, visit www.latisse.com. information, visit www.ferringusa.com or call 888-337-7464. New indication ConvaTec announced that it has received expanded indications from the FDA for its Aquacel and Aquacel Ag hydrofiber Advertiser Index dressings for the manageASTEPRO Meda Pharmaceuticals ment of surgical wounds AXONA Accera Inc. that heal by primary inCORPORATE Actavis tent. The Aquacel Ag CORPORATE EPS, Inc. dressing provides the CORPORATE Fougera broad-spectrum antiCORPORATE Kirby Lester microbial properties of ionic silver, which kills CORPORATE Mylan Pharmaceuticals Inc. a broad range of pathoCORPORATE QS/1 gens, including methicilCORPORATE ScriptPro lin-resistant StaphylococCORPORATE Teamstaff RX cus aureus (MRSA) and CORPORATE Teva Pharmaceuticals USA vancomycin-resistant EFFIENT B2B Eli Lilly and Company enterococci (VRE). For ENTEREG GlaxoSmithKline more information, visit www.convatec.com. FLEXPEN JANUVIA KAPIDEX LICEMD MOXATAG TRILIPIX VECTICAL ZOSYN ZYRTEC OTC Novo Nordisk Merck & Company available in the 100 mg/mL strength and is the generic equivalent of UCB’s Keppra(R) Oral Solution. Levetiracetam Oral Solution is used in the treatment of partial onset seizures in adults and children with epilepsy. More information about Actavis in the United States can be found at www.actavis.us. Sun announced it has received final approval from the FDA for several abbreviated new drug applications (ANDAs). Approval was received for generic hydrocodone bitartrate with acetaminophen (APAP) tablets. Approval was also received for pamidronate disodium for injection USP (generic Aredia), gemfibrozil tablets (generic Lopid), and promethazine hydrochloride tablets USP (generic Phenergan). Visit www.sunpharma.com for more information. Watson announced that its subsidiary, Watson Laboratories, has received final approval from the FDA on its ANDA for Azurette (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg), the generic equivalent of Duramed’s Mircette, a low-dose monthly Continued on pg. 58 oral contraceptive 53-54 27 59 HSE7 3 5 CV2-p.1 39 7 CV3 15 51 HSE2-4 CV4 INSERT 17-19 35 9-10 29-33 23-24 HSE9-11 13 Ferring announced the FDA recently approved the injectable drug degarelix, the first new drug in several years for treatment of prostate cancer. Degarelix is intended for patients with advanced prostate cancer. For more New generics Actavis Group announced that it has received approval from the FDA to market Levetiracetam Oral Solution [1]. Levetiracetam Oral Solution is Takeda Pharmaceuticals North America Inc. Combe Inc. Middlebrook Pharma Abbott Laboratories Galderma Laboratories Inc. Wyeth Mc Neil Consumer 52 DRUG TOPICS March 2009 COURTESY ACTAVIS (1), MCNEIL CONSUMER HEALTHCARE (2), AGROLABS (3) http://www.actavis.us http://www.sunpharma.com http://www.sunpharma.com http://www.ferringusa.com http://www.cypressbio.com http://www.convatec.com http://www.latisse.com
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.